Enbrel

Enbrel

etanercept

Manufacturer:

Pfizer
Concise Prescribing Info
Contents
Etanercept
Indications/Uses
Active RA, alone or in combination w/ methotrexate, in adults w/ inadequate response to disease-modifying antirheumatic drugs; severe, active & progressive RA in adult - not previously treated w/ methotrexate; active polyarticular-course juvenile chronic arthritis in childn 4-17 yr who have had an inadequate response to, or who have proved intolerant of methotrexate; active & progressive psoriatic arthritis, severe active ankylosing spondyilitis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate; adults (≥18 yr) w/ moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA.
Dosage/Direction for Use
Adult 18-64 yr RA 25 mg twice wkly. Alternatively, 50 mg once wkly. Psoriatic arthritis & ankylosing spondyilitis 25 mg SC twice wkly, alternatively, 50 mg once wkly. Plaque psoriasis 25 mg SC twice wkly, alternatively, 50 mg twice wkly may be used up to 12 wk followed, if necessary, by dose 25 mg twice wkly. Treatment should continue until remission is achieved for up to 24 wk. Discontinue in patients who show no response after 12 wk. Elderly ≥65 yr Same as for adults 18-64 yr. Childn & adolescent (≥4 to <18 yr) 0.4 mg/kg SC (up to max of 25 mg/dose) twice wkly w/ interval 3-4 days between doses.
Contraindications
Hypersensitivity. Patients w/ active chronic or localized infections. Sepsis or risk of sepsis.
Special Precautions
History of recurring or chronic infections or w/ underlying conditions which may predispose patients to infections eg, advanced or poorly controlled diabetes. Concurrent Enbrel & anakinra treatment. Wegener's granulomatosis. Alcoholic hepatitis. Allergic reactions. Immunosuppression. Malignancies & lymphoproliferative disorders. Skin cancer. Live vaccines should not be given concurrently. Autoantibody formation. Haematologic reactions. Neurological disorders. Combination therapy. CHF. TB. Hepatitis B reactivation. Worsening of hepatitis C. Hypoglycemia in patients treated for diabetes. Inflammatory bowel disease (IBD) in patients w/ juvenile idiopathic arthritis (JIA). Renal & hepatic impairment. Pregnancy & lactation. Childn <4 yr.
Adverse Reactions
Inj site reactions, infections, allergic reactions, autoantibody formation, pruritus, fever, headache, malignancies & lymphoproliferative disorders, pancytopenia & aplastic anaemia.
Drug Interactions
Higher rate of serious infections in concurrent treatment w/ anakinra. Sulfasalazine.
ATC Classification
L04AB01 - etanercept ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Enbrel inj 50 mg
Packing/Price
(pre-filled syringe) 2 × 1's (Rp5,885,000/boks)
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